Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Laboratory Accreditation for Analyses of Foods, 103836-103838 [2024-30230]
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103836
Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Food Labeling: Notification Procedures
for Statements on Dietary
Supplements—21 CFR 101.93
OMB Control Number 0910–0331—
Extension
Section 403(r)(6) of the FD&C Act (21
U.S.C. 343(r)(6)) and § 101.93 (21 CFR
101.93) require that, no later than 30
days after the first marketing, we be
notified by the manufacturer, packer, or
distributor of a dietary supplement that
it is marketing a dietary supplement
product that bears on its label or in its
labeling a statement provided for in
section 403(r)(6) of the FD&C Act. In
accordance with these requirements,
submissions must include: (1) the name
and address of the manufacturer,
packer, or distributor of the dietary
supplement product; (2) the text of the
statement that is being made; (3) the
name of the dietary ingredient or
supplement that is the subject of the
statement; (4) the name of the dietary
supplement (including the brand name);
and (5) the signature of a responsible
individual or the person who can certify
the accuracy of the information
presented, and who must certify that the
information contained in the notice is
complete and accurate, and that the
notifying firm has substantiation that
the statement is truthful and not
misleading.
Our electronic form (Form FDA 3955)
allows respondents to the information
collection to electronically submit
notifications to FDA via the Food
Applications Regulatory Management
(FARM) system. Firms that prefer to
submit a paper notification in a format
of their own choosing still have the
option to do so; however, Form FDA
3955 prompts respondents to include
certain elements in their structure/
function claim notification (SFCN)
described in § 101.93 in a standard
electronic format and helps respondents
organize their SFCN to include only the
information needed for our review of
the claim. Note that the SFCN, whether
electronic or paper, is used for all
claims made pursuant to section
403(r)(6) of the FD&C Act, including
nutrient deficiency claims and general
well-being claims in addition to
structure/function claims. The
electronic form, and any optional
elements prepared as attachments to the
form (e.g., label), can be submitted in
electronic format via FARM.
Submissions of SFCNs will continue to
be allowed in paper format. We use this
information to evaluate whether
statements made for dietary ingredients
or dietary supplements are permissible
under section 403(r)(6) of the FD&C Act.
We also provide information on our
website at https://www.fda.gov/food/
information-industry-dietarysupplements/notificationsstructurefunction-and-related-claimsdietary-supplement-labeling, which may
serve as a helpful resource to
respondents.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packers, or distributors of dietary
supplements that bear section 403(r)(6)
of the FD&C Act statements on their
labels or labeling.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity; form No.
101.93; Statements for Dietary Supplements; Form FDA
3955.
1 There
3,690
Total annual
responses
1
3,690
Average burden per
response
0.75 (45 minutes) ..
Total
hours
2,768
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
This estimate is based on our experience
with this information collection and the
number of notifications received in the
past 3 years, which has remained
constant.
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Dated: December 12, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3379]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Laboratory
Accreditation for Analyses of Foods
[FR Doc. 2024–30231 Filed 12–18–24; 8:45 am]
AGENCY:
BILLING CODE 4164–01–P
HHS.
ACTION:
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Food and Drug Administration,
Notice.
Frm 00073
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Sfmt 4703
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 21,
2025.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
SUMMARY:
E:\FR\FM\19DEN1.SGM
19DEN1
Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0898. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Laboratory Accreditation for Analysis
of Foods
OMB Control Number 0910–0898—
Extension
This information collection helps to
support implementation of FDA’s
statutory and regulatory authority
governing our laboratory accreditation
for analysis of foods program under
section 422 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350k) and
21 CFR part 1, subpart R. FDA has
statutory authority to establish a
program for the testing of food by
accredited laboratories; to establish a
publicly available registry of recognized
accreditation bodies and laboratories
recognized by an accreditation body;
and to require reports of any changes
that would affect the recognition of such
accreditation body or the accreditation
of such laboratory.
The regulations require respondents
to maintain and electronically submit
certain test results, reports,
notifications, and other records to FDA.
We are clarifying that the information
collection includes the use of an
electronic information collection system
(the FURLS Laboratory Accreditation for
Analyses of Foods Program portal) (FDA
Industry Systems). User guides for the
Accreditation Bodies and Accredited
Laboratories can be found at the
following links: https://www.fda.gov/
media/156097/download?attachment
and https://www.fda.gov/media/161685/
download?attachment. The laboratory
accreditation program helps fulfill
FDA’s mandate to ensure the safety of
the U.S. food supply and protect U.S.
consumers by administering appropriate
oversight of certain food testing that is
of importance to public health. It also
helps ensure that the testing is done in
accordance with appropriate model
103837
standards, which will help produce
consistently reliable and valid test
results. You may access additional
information about the laboratory
accreditation program at: https://
www.fda.gov/food/food-safetymodernization-act-fsma/fda-recognizedaccreditation-bodies-laboratoryaccreditation-analyses-foods-laafprogram. The public registry is available
at https://datadashboard.fda.gov/ora/
fd/laaf.htm.
Respondents to the information
collection are accreditation bodies
seeking recognition from FDA,
recognized accreditation bodies,
laboratories seeking accreditation from
recognized accreditation bodies, and
accredited laboratories. Participation in
this program is voluntary for
laboratories and accreditation bodies;
however, only recognized accreditation
bodies would be able to accredit
laboratories to conduct food testing as
specified in the regulations.
In the Federal Register of August 15,
2024 (89 FR 66417), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 2
lotter on DSK11XQN23PROD with NOTICES1
§§ 1.1113 and 1.1114; Accreditation bodies (ABs)
application for recognition (one-time submission).
§§ 1.1113 and 1.1114; ABs—application for renewal
of recognition.
§ 1.1123; ABs—reports, notifications, and documentation requirements.
§ 1.1116(a) and (b); ABs—notices of intent to relinquish, records custodian.
§§ 1.1138 and 1.1139; laboratories—submission of
application for LAAF-accreditation (one-time submission).
§§ 1.1149(a) and 1.1152(c)(1), (2); laboratories—
submission of sampling plan, sample collection report, and sampler qualifications.
§§ 1.1152(d) and 1.1153(a); laboratories—qualification to submit abridged analytical reports (onetime submission).
§ 1.1153; laboratories—abridged analytical reports
submissions.
§ 1.1149(c); laboratories—advance notice of sampling submissions.
§ 1.1152(f); laboratories—immediate notification.
§ 1.1140(a); laboratories—notices of intent to relinquish, records custodian.
§ 1.1152(c)(4) and (5); laboratories—validation and
verification studies submissions.
§§ 1.1142; 1.1171; 1.1173; and 1.1174; requests in
response to FDA action.
Total ....................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average burden per
response
2.2068 (2 hours and
12 minutes).
8
44
352
1
3
3
160
63.5
10,160
2
3
6
1 ..............................
6
50
5
250
375
1
1
1
1.5 (1 hour and 30
minutes).
1 ..............................
........................
........................
10,772
.................................
19,508
3 ..............................
1.8051 (1 hour and
49 minutes).
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
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Sfmt 4703
E:\FR\FM\19DEN1.SGM
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776.8
9
18,340
1
103838
2 Totals
Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices
may not sum due to rounding.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 2
Number of
recordkeepers
21 CFR section; activity
§ 1.1113; recordkeeping associated with ISO/IEC
17011:2017.
§ 1.1124; ABs—additional recordkeeping requirements a recognized accreditation body must
maintain, for 5 years after the date of creation of
the records, records created while it is recognized
demonstrating its compliance with this subpart.
§ 1.1138; laboratories—becoming accredited to ISO/
IEC 17025:2017 (one-time); Laboratories adding
ISO 17025 to become LAAF-accredited.
§ 1.1138; laboratories—maintaining ISO/IEC 17025:
2017 accreditation.
§ 1.1154; laboratories—additional recordkeeping requirements; a LAAF-accredited laboratory must
maintain, for 5 years after the date of creation,
records created and received while it is LAAF-accredited that relate to compliance with this subpart.
Total ....................................................................
1 There
2 Totals
Total annual
records
Average burden per
recordkeeping
Total hours
8
2
8
22 ............................
176
9
1
9
91.06 (91 hours and
4 minutes).
820
160
2
320
450.765 (450 hours
and 46 minutes).
144,245
........................
........................
345
.................................
145,241
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
The burden we attribute to reporting
and recordkeeping activities is assumed
to be distributed among the individual
elements of the respective information
collection activities. Although we have
not received a notice of intent to
relinquish records since the last
approval of this information collection,
we include one response for the purpose
of estimating burden.
We calculate the number of food
testing laboratories seeking
accreditation based on the number of
applicants. As a result, the number of
respondents to the information
collection decreased (from 170
respondents in the currently approved
collection to 160 respondents).
Consequently, we have adjusted our
burden estimate, which results in a
decrease of 227 responses and 9,303
burden hours from the currently
approved information collection.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–30230 Filed 12–18–24; 8:45 am]
BILLING CODE 4164–01–P
lotter on DSK11XQN23PROD with NOTICES1
Number of
records per
recordkeeper
VerDate Sep<11>2014
18:08 Dec 18, 2024
Jkt 265001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Additives
Intended for Use in Animal Food, Food
Additive Petitions, Investigational
Food Additive Files Exemptions, and
Declaration on Animal Food Labels
Food and Drug Administration,
HHS.
ACTION:
Electronic Submissions
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions associated with
food additives intended for use in
animal food, food additive petitions,
investigational food additive files
exemptions, and declaration of color
additives on animal food labels.
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
February 18, 2025. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
ADDRESSES:
[Docket No. FDA–2024–N–5581]
AGENCY:
Either electronic or written
comments on the collection of
information must be submitted by
February 18, 2025.
DATES:
Sfmt 4703
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
E:\FR\FM\19DEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103836-103838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30230]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3379]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Laboratory
Accreditation for Analyses of Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 21, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
[[Page 103837]]
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0898. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Laboratory Accreditation for Analysis of Foods
OMB Control Number 0910-0898--Extension
This information collection helps to support implementation of
FDA's statutory and regulatory authority governing our laboratory
accreditation for analysis of foods program under section 422 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350k) and 21 CFR part
1, subpart R. FDA has statutory authority to establish a program for
the testing of food by accredited laboratories; to establish a publicly
available registry of recognized accreditation bodies and laboratories
recognized by an accreditation body; and to require reports of any
changes that would affect the recognition of such accreditation body or
the accreditation of such laboratory.
The regulations require respondents to maintain and electronically
submit certain test results, reports, notifications, and other records
to FDA. We are clarifying that the information collection includes the
use of an electronic information collection system (the FURLS
Laboratory Accreditation for Analyses of Foods Program portal) (FDA
Industry Systems). User guides for the Accreditation Bodies and
Accredited Laboratories can be found at the following links: https://www.fda.gov/media/156097/download?attachment and https://www.fda.gov/media/161685/download?attachment. The laboratory accreditation program
helps fulfill FDA's mandate to ensure the safety of the U.S. food
supply and protect U.S. consumers by administering appropriate
oversight of certain food testing that is of importance to public
health. It also helps ensure that the testing is done in accordance
with appropriate model standards, which will help produce consistently
reliable and valid test results. You may access additional information
about the laboratory accreditation program at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fda-recognized-accreditation-bodies-laboratory-accreditation-analyses-foods-laaf-program. The public
registry is available at https://datadashboard.fda.gov/ora/fd/laaf.htm.
Respondents to the information collection are accreditation bodies
seeking recognition from FDA, recognized accreditation bodies,
laboratories seeking accreditation from recognized accreditation
bodies, and accredited laboratories. Participation in this program is
voluntary for laboratories and accreditation bodies; however, only
recognized accreditation bodies would be able to accredit laboratories
to conduct food testing as specified in the regulations.
In the Federal Register of August 15, 2024 (89 FR 66417), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 1.1113 and 8 44 352 2.2068 (2 hours 776.8
1.1114; Accreditation bodies and 12 minutes).
(ABs) application for
recognition (one-time
submission).
Sec. Sec. 1.1113 and
1.1114; ABs--application for
renewal of recognition.
Sec. 1.1123; ABs--reports,
notifications, and
documentation requirements.
Sec. 1.1116(a) and (b); ABs-- 1 3 3 3............... 9
notices of intent to
relinquish, records custodian.
Sec. Sec. 1.1138 and 160 63.5 10,160 1.8051 (1 hour 18,340
1.1139; laboratories-- and 49 minutes).
submission of application for
LAAF-accreditation (one-time
submission).
Sec. Sec. 1.1149(a) and
1.1152(c)(1), (2);
laboratories--submission of
sampling plan, sample
collection report, and
sampler qualifications.
Sec. Sec. 1.1152(d) and
1.1153(a); laboratories--
qualification to submit
abridged analytical reports
(one-time submission).
Sec. 1.1153; laboratories--
abridged analytical reports
submissions.
Sec. 1.1149(c);
laboratories--advance notice
of sampling submissions.
Sec. 1.1152(f);
laboratories--immediate
notification.
Sec. 1.1140(a); 2 3 6 1............... 6
laboratories--notices of
intent to relinquish, records
custodian.
Sec. 1.1152(c)(4) and (5); 50 5 250 1.5 (1 hour and 375
laboratories--validation and 30 minutes).
verification studies
submissions.
Sec. Sec. 1.1142; 1.1171; 1 1 1 1............... 1
1.1173; and 1.1174; requests
in response to FDA action.
---------------------------------------------------------------------------------
Total..................... .............. .............. 10,772 ................ 19,508
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 103838]]
\2\ Totals may not sum due to rounding.
Table 2--Estimated Annual Recordkeeping Burden\1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec. 1.1113; recordkeeping 8 2 8 22.............. 176
associated with ISO/IEC
17011:2017.
Sec. 1.1124; ABs--additional
recordkeeping requirements a
recognized accreditation body
must maintain, for 5 years
after the date of creation of
the records, records created
while it is recognized
demonstrating its compliance
with this subpart.
Sec. 1.1138; laboratories-- 9 1 9 91.06 (91 hours 820
becoming accredited to ISO/ and 4 minutes).
IEC 17025:2017 (one-time);
Laboratories adding ISO 17025
to become LAAF-accredited.
Sec. 1.1138; laboratories-- 160 2 320 450.765 (450 144,245
maintaining ISO/IEC 17025: hours and 46
2017 accreditation. minutes).
Sec. 1.1154; laboratories--
additional recordkeeping
requirements; a LAAF-
accredited laboratory must
maintain, for 5 years after
the date of creation, records
created and received while it
is LAAF-accredited that
relate to compliance with
this subpart.
---------------------------------------------------------------------------------
Total..................... .............. .............. 345 ................ 145,241
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Totals may not sum due to rounding.
The burden we attribute to reporting and recordkeeping activities
is assumed to be distributed among the individual elements of the
respective information collection activities. Although we have not
received a notice of intent to relinquish records since the last
approval of this information collection, we include one response for
the purpose of estimating burden.
We calculate the number of food testing laboratories seeking
accreditation based on the number of applicants. As a result, the
number of respondents to the information collection decreased (from 170
respondents in the currently approved collection to 160 respondents).
Consequently, we have adjusted our burden estimate, which results in a
decrease of 227 responses and 9,303 burden hours from the currently
approved information collection.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30230 Filed 12-18-24; 8:45 am]
BILLING CODE 4164-01-P
